What is a Narrative?

A narrative is a small document (100-500 words) that is required by the Food and Drug Administration to briefly describe the events in the life of a subject. These are required when the subject enrolled in a study or within 30 days of taking study medication discontinued the study because of an adverse event, had 1 or more serious adverse events or died. Serious adverse events are defined as events resulting in death, are life threatening, requiring hospitalization or resulting in persistent or significant disability1. Narratives are written in combination with clinical study reports and with the 60-day PSUR (periodic safety update report), however, the E2C has no specific requirements for how narratives (called individual case safety reports) should be presented. Shortened narratives may be included in the body of a clinical study report in order to provide support for an observation about a cluster of events. Sources of Information in Narratives Narratives are written from 2 sources: 1. From safety reports maintained by the Safety Officer, who is a physician working on-site 2. From the clinical database maintained by the Statistics Department Information from Safety Reports Safety reports are also called CIOMS reports or SAE reports. Safety reports are written by the Safety Officer or by a writer working under his supervision and are required for any subjects with a serious adverse events which emerged during a clinical trial and also for any patient with serious adverse events that have emerged when taking approved drugs (post-marketing). Each time a death or serious adverse event occurs in a subject in a clinical trial or a patient taking the drug after it has been approved, a new report has to be written and filed with the FDA within 15 days. Introduction Overview of Case handling process: A drug safety department in a pharmaceutical company performs many functions, although corporate structures in the pharmaceutical industry are extremely diverse in how the drug safety function fits within the company. Drug safety work may be performed within the regulatory function, the medical affairs function, the clinical development function, or as an independent area. The remit of drug safety may also be variously defined to include medical information activities, product complaint management, and submission of regulatory documents, Pharmacoepidemiology and/or safety support of clinical trials, as well as safety surveillance and other pharmacovigilance activities. However, the task most common to all safety departments is the reporting of adverse events to health authorities according to regulatory requirements. The process of collecting, processing, analyzing, and reporting adverse event (AE) information will be collectively referred to here as the casehandling process. In addition to maintaining regulatory compliance, this process is a key component of pharmacovigilance. Effective monitoring of drug safety not only requires a systematic approach to collection of information, but a means of organizing that information into a database that allows retrieval in a format amenable to screening and analysis. Much of the safety data available to a pharmaceutical company regarding its products arises from individual reports of AEs. Without effective management of this data through the case

handling process, pharmaceutical companies would be less able to understand the evolving benefit-to-risk balance of their products in order to act responsibly in protecting patients. Case processing aspects: In Case handling process, after triage of case, Case processing is started by any drug safety professional. Case processing is the creation of a case in the safety database from source information. Case processing includes the tasks of data entry into the safety database from source documents, coding (AEs, medical history, concomitant conditions, concomitant medications, etc.), writing the case narrative and identifying missing information that should be pursued in follow-up. Drug coding using a standardized dictionary is also done. And after coding steps, the case narrative is usually written at this point. In particular, this involves the creation of the narrative (which is a stand-alone text summary of the case that appears in the electronic case [E2B] or on the MedWatch and CIOMS I forms), and the verification of drug names, dosages, past medical history, and so on. Case Narrative Definition and Overview: It is defined as a medical report containing all known relevant clinical and related information, including patient characteristics, therapy details, medical history, clinical course of the event(s), diagnosis, adverse reactions including the outcome, relevant laboratory evidence (including normal ranges) and any other information that supports or refutes an adverse reaction. It is a part of ICSR narrating comprehensive and complete medical description of the case or AE observed during clinical investigation or post marketing surveillance. Provides information on AE/SAE case in well mannered paragraph format. It should serve as stand-alone comprehensive text summary of the case that appears in the electronic case It is task of drug safety professional ideally created manually or automatically by safety database software. Objective and Importance: Objective: Its main aim is to summarize all relevant clinical and related information, including patient characteristics, therapy details, medical history, clinical course of the event(s), diagnosis, and ADR(s) (including the outcome, laboratory evidence and any other information that supports or refutes an ADR). Importance: It is an important part of pharmacovigilance and patient safety, with case narratives being required for Individual Case Safety Reports, from both clinical and post-marketing studies. The correct coding of this information captured in narrative has a significant impact on the ability to perform qualitative signal detection and evaluation. Characteristics of Case Narrative Case narrative writing is an important part of pharmacovigilance and patient safety. Case narratives are required for Individual Case Safety Reports, from both clinical studies and post-marketing studies. So, A Typical case narrative has some of the criteria that have to be fulfilled to consider it as an ideal case narrative. Following characteristics must be included in an ideal case narrative. The Narrative should serve as a comprehensive, stand-alone medical story.

A company case narrative is different from the reporters clinical description of a case, though the reporters comments should be an integral part of the company narrative. The reporters verbatim words should be included for the adverse reactions. The information should be presented in a logical time sequence; ideally this should be presented in the chronology of the patients experience, rather than in the chronology in which the information was received. In follow-up reports, new information should be clearly identified. Abbreviations and acronyms should be avoided, with the possible exception of laboratory parameters and units. Key information from supplementary records should be included in the report and their availability should be mentioned in the narrative and supplied on request. Any autopsy or other post-mortem findings (including a coroners report) should also be provided when available if allowed by local privacy protection laws. Terms in the narrative should be accurately reflected by appropriate coding. Narratives should be prepared for all serious (expected and unexpected) and non serious unexpected cases but not for non serious expected cases. Narratives should be written in the third person past tense. Time to onset of an event from the start of treatment should be given in the most appropriate time units (e.g., hours), but actual dates can be used if helpful to the reader. Information may be supplied by more than one person (e.g., initial reporter and supplementary information from a specialist); all sources should be specified. When there is conflicting information provided from different sources, this should be mentioned and the sources identified. If it is suspected that an ADR resulted from misprescribing (e.g., wrong drug or wrong dose) or other medication error, judgmental comments should not be included in the narrative because of legal implications. Only the facts should be stated (e.g., four times the normal dose was administered, the prescription was misread and a contraindicated drug for this patient was given).

Sections of Case Narrative A typical case narrative either for clinical or for spontaneous case, has following sections. Types of the report, reporter and patient demography: This section includes narration of type of report and Patient demography. Type of report: Reports can be received as Spontaneous, Clinical Trial, Post Marketing, Solicited, or Literature report. Reporter This section includes information of reporter. Reporter can be Patient, Healthcare professional, Doctor, Nurse, Pharmacist, Investigator or any health care professional. Patient demography: In this part, information of patients is mentioned such as, age, sex, date of birth, weight, height, ethnicity etc. But, note that Patient name or address cant be mentioned here.

Medical and drug history: This section contains list of medically relevant drug history with respect the adverse drug reaction and list of medically relevant medical history with respect the adverse drug reaction. Suspect drugs: This section enlists information about suspect drug. 1. Name 2. Dose 3. Regimen 4. Indication 5. Timing 6. Conditions surrounding onset of reaction 7. Mfg and Exp. Date 8. Route of administration etc Progressions of event and Outcome: In this section, progression of event experienced by patient and their relevant outcome are described in chronological order. Details of adverse event and its progression and consequences are narrated with following information in detail: 1. Seriousness/ non seriousness 2. Expected/unexpected 3. Causality (e.g. related/not related) 4. Action taken (e.g. medicine dose reduced, discontinue the drug for while, stop the drug permanently, new drug or treatment started, any surgery performed etc.) 5. Outcome (e.g. recovering, recovered with sequel, recovered, death, unknown, etc.) Medical Evaluation and Comment: In this section, any evaluation or any special comment on causality or outcome received from reporter (i.e. any health professional or author of literature case) is described at the end of narrative paragraph. Case Narrative essential details The sections mentioned above must have following details to be included in a typical case narrative. The manner in which you were informed The date and time you were informed The nature of the event The date and time of the event Participants history in the study (i.e., date when randomized onto drug, length of time on study drug, when the last dose was taken, the last visit before the SAE, condition at last visit before the SAE Relevant lab results Medications prescribed (include dose) Discharge information (date and time, condition upon discharge) Medications prescribed upon discharge Follow-up plans

 PIs assessment of relationship between AE/SAE and protocol or study drug Any other relevant information (details are important) IRB Adverse Event & IND Safety Reporting Cumulative Table Approaches to Case Narrative in Safety Database Case narrative is an important part of pharmacovigilance and patient safety, with case narratives being required for Individual Case Safety Reports, from both clinical and post-marketing studies. Furthermore case narrative is a comprehensive, stand-alone medical story. So it requires special skills and talent to create concise, accurate and well-written case narratives available from relevant, related information from various source documents. Only skilled persons with health care back round (e.g. RN, RPH, physician, etc) like drug safety associates or drug safety physicians are responsible for this task in major companies or CROs. This is a part of Case processing process, so it is handled by only one person at a time in safety database like ARGUS, ArisG, and Clintrace etc. Approach to case narrative in safety database by drug safety associate: 1. Triaged cases assigned to DSA for case processing by Manager 2. Open one case in safety database 3. All information must have been entered in database while registering case initially. 4. Open source document tab for that case 5. Check and match all information entered in database with source document. 6. Fill up and confirm all required and related information for that case if needed or information missing. 7. Open Narrative/analysis tab in database. 8. Select auto narration tab for auto narrative that will generate draft auto narrative for that case. 9. Copy and paste that narrative paragraph in separate MS Word file. 10. By using your medical judgment, skills, source document information, create concise, accurate and wellwritten case narrative for that case. 11. Copy and paste that narrative in Safety database and route case to further process. Types of Case for Case Narrative Generally, cases received by company are of mainly following types. Post marketing or Spontaneous cases: A spontaneous report is an unsolicited communication by a healthcare professional or consumer to a company, regulatory authority or other organization (e.g. WHO, Regional Center, Poison Control Center) that describes one or more adverse drug reactions in a patient who was given one or more medicinal products and that does not derive from a study or any organized data collection scheme. Spontaneous SAEs and non serious cases arrive by telephone (the most common route of arrival in many companies); websites; electronically; e-mail; snail mail; fax; reports to sales representatives; reports to other company employees, agents, or contractors; the legal department; health authorities (e.g., FDA, MHRA, Health Canada); other companies who receive AEs on their own drugs in which one of their drugs is involved; and other miscellaneous sources such as newspaper, social media, or TV stories. They are received primarily from consumers, healthcare professionals, and lawyers. Clinical or Study cases:

Clinical studies: Clinical study events may come in from the companys clinical research and clinical pharmacology departments as well as any other group that might (often unbeknown to the drug safety department) run studies. Such groups might be in marketing, subsidiaries, affiliates, market research, pharmacoepidemiology, pharmacoeconomics, or other companies that are studying the drug with your company or are studying the drug without your companys consent and knowledge. AEs may also arrive from contract research organizations. Literature cases: Cases of ADRs from the scientific and medical literature, including relevant published abstracts from meetings and draft manuscripts, might qualify for expedited reporting. A regulatory reporting form with relevant medical information should be provided for each identifiable patient. The publication reference(s) should be given as the report source; additionally a copy of the article might be requested by the local regulatory authority to accompany the report. All company offices are encouraged to be aware of publications in their local journals and to bring them to the attention of the company safety department as appropriate. Others: Other category consists of cases received as pregnancy cases, infant/ child cases, litigation cases (e.g. legal cases). Steps for Narrative writing The Narrative should serve as a comprehensive, stand-alone medical story. So, there must be some specific step sequence to write narrative in Paragraph format. It cannot be written in random manner. All information must be narrated in particular sequence in narration so that reader can access and understand entire case clearly and not even single information of case is missed. In order to cope up with that, special step sequence for each type of cases has been used in most of companies or CRO. Post marketing or Spontaneous cases: Step sequence for narrative writing of Post marketing cases and spontaneous cases is as follow. 1. Type of source (e.g. spontaneous in this case, others may be clinical, litigation, literature, stimulated, etc) 2. Reporter information (e.g. age, sex, profession etc). No name and address are included. 3. Patient information (e.g. age, sex, weight, height, country of event, local case ID, and for Clinical trial cases, site ID, randomized/not randomized study, etc). No name and address are included. 4. Patient medical history, social and drug history 5. Suspect drug information such as, name of drug, dose, dose frequency, and formulation, and indication, route of administration, batch no., and exp. And mfg. date, etc. 6. Concomitant drug information such as, indication, dose, name, etc. 7. AE term information with lab data, any other treatment if provided. 8. Action taken with drug such as, dose reduced; discontinued for while, discontinue permanently, other treatment or surgery etc.

9. Outcome such as, recovering, not recovered, recovered with sequel, fully recovered death, unknown etc. 10. Causality statement such as related/not related. Clinical or Study cases: Step sequence for narrative writing of clinical cases and spontaneous cases is as follow. 1. Protocol narration 2. Type of source (e.g. spontaneous in this case, others may be clinical case, litigation, literature, stimulated, etc) 3. Reporter information (e.g. age, sex, profession etc). No name and address are included. 4. Patient information (e.g. age, sex, weight, height, country of event, local case ID, and for Clinical trial cases, site ID, randomized/not randomized study, etc). No name and address are included. 5. Patient medical history, social and drug history 6. Suspect drug information such as, name of drug, dose, dose frequency, and formulation, and indication, route of administration, batch no., and exp. And mfg. date, etc. 7. Concomitant drug information such as, indication, dose, name, etc. 8. AE term information with lab data, any other treatment if provided. 9. Action taken with drug such as, dose reduced; discontinued for while, discontinue permanently, other treatment or surgery etc. 10. Outcome such as, recovering, not recovered, recovered with sequel, fully recovered death, unknown etc. 11. Causality statement (Investigator causality or company causality) such as related/not related. Literature cases: Step sequence for narrative writing of literature cases and spontaneous cases is as follow. 1. Type of source (e.g. spontaneous in this case, others may be clinical, litigation, literature case, stimulated, etc) 2. Reporter information (e.g. age, sex, profession etc). No name and address are included. 3. Patient information (e.g. age, sex, weight, height, country of event, local case ID, and for Clinical trial cases, site ID, randomized/not randomized study, etc). No name and address are included. 4. Patient medical history, social and drug history 5. Suspect drug information such as, name of drug, dose, dose frequency, and formulation, and indication, route of administration, batch no., and exp. And mfg. date, etc. 6. Concomitant drug information such as, indication, dose, name, etc.

7. AE term information with lab data, any other treatment if provided. 8. Action taken with drug such as, dose reduced; discontinued for while, discontinue permanently, other treatment or surgery etc. 9. Outcome such as, recovering, not recovered, recovered with sequel, fully recovered death, unknown etc. 10. Causality statement such as related/not related. 11. Author comment 12. Literature citation. Information from an Unlocked Database If narratives are being written for subjects in ongoing studies, the database will consist of case report forms filled out by the investigator at the site and perhaps a preliminary listings database prepared from the information in the case report forms. The case report forms may not have been cleaned, so each date or tick or entry may be queried and each query may not yet have been answered. Information from a Locked Clinical Database If the narratives being written are for completed studies, the data from the case report forms may have been cleaned and locked and transferred onto listings and end-of-text tables. The clinical database will stay the same after it has been locked, unless a huge error has somehow crept in, in which case the database can be opened, changed and locked again. These changes are not seen as often as having the listings change. The listings are the way the data in the clinical database are presented in groups, eg, by age, by sex, by study day, by adverse events, by medical and surgical therapy before receiving study medication, by concomitant medications during study therapy. Once the data are locked, new listings can be generated for different reasons, eg, if the Safety Officer or other clinical watchdog group becomes aware of a cluster of the same serious adverse event in a post-marketing patient population and they want to see if this same event occurred but was unobserved in the clinical trials database. Other more mundane reasons is that the programs generating the listings were flawed and the listings did not capture all the subject data needed. Types of Narratives Narratives written on subjects in completed studies If databases have been cleaned and locked, all the information for narratives are in listings and in the safety reports. Narratives written on subjects in ongoing studies If the studies are ongoing, the first step is to determine the cut-off date. The cut-off date locks the time period for serious adverse event reporting and needs to be at least 3 months before the date that the narratives are being written. Only subjects whose events occurred by the cut-off date and whose events were reported within the following 3 months will be included in the data analysis and will have narratives written Narratives written post-marketing These narratives have a different nature than those written for subjects in controlled studies, because the only information the Sponsor has about the patient has come from the reporting physician and thus they are entirely

written from the safety reports obtained from the Safety Officer. Any numbers on serious adverse events calculated post-marketing are undercounted, reasons for undercounting include patients not telling healthcare professionals which drugs they are taking and also, patients not reporting serious adverse events to healthcare professionals. With chemotherapy drugs, this is less likely to be so. Preferred terms, Investigator Terms and System-Organ Class Because the same event occurring in two different people can be recorded differently by different investigators, dictionaries have been devised to group terms together. The dictionary most widely used is the WHOART dictionary. The ICD-9 code is a step further, after the terms have been grouped together they are assigned a number. The ICD-9 code was adapted from the WHOART dictionary by the Centers of Disease Control in order to track mortality and morbidity data. The ICD-10 code is becoming the more frequently used coding system. The Safety Officer, or someone working under his supervision, has the task of taking what the investigator said was the adverse event, and coding this into terms that can be added to databases and sorted in order to find clusters of adverse events that are associated with drug use. The words the investigator uses are called the Investigator Terms or the Verbatim Terms. The Safety Officer decides which Preferred Term this most approximates. Examples of Investigator Terms are heart attack and myocardial infarction which are then coded to the Preferred Term myocardial infarction. A further sort of Preferred Terms is made by the Safety Officer who codes Preferred Terms as System-OrganClass. When a verbatim term has been assigned a preferred term, that is the term that is used to describe the event in the tops of the narratives and throughout the clinical study report. The verbatim term only appears in the body of the narrative and in other documents only when identified as the verbatim term. Writing the Narrative A clinical trial of any size can result in a large number of subjects having serious adverse events, a large clinical trial including a large number of very ill subjects with advanced cancer can result in the majority of subjects having serious adverse events. The aim of narrative writing is to have a concise document that looks like all the other narratives so the FDA reviewers can easily move from 1 to the next, finding the same type of information in the same place in each document, and finding key pieces of information. A pile of narratives is like having consecutive frames in a film, by the time you have read through every one, you have a clear idea of the diseases and injuries afflicting the subject population and you have a clear idea whether the study medication is to blame. Because any piece of information moved to another part of the document can upset the rhythm, narratives should be written in as uniform a manner as possible. To achieve this, narratives are best written from a template in which styles have been preset and hidden text gives prompts. Identifying information The information in the top of the narrative identifies the subject (by subject identifying number), the clinical trial (by clinical trial number), the study medication the subject had been taking with the dose, the dates the subject was in the clinical trial, and the serious adverse events by preferred term The Body of the Narrative The narrative is a stylized document, with at least 4 paragraphs. The number of paragraphs will increase from 4 only if more than 1 serious adverse event emerged during treatment. In the narrative body, the medical reviewer should find enough information to understand what happened and why without having to wade through information that does not lead to his or her understanding of why this event was coded a serious event. The first paragraph: In the first sentence, explain when the subject was diagnosed with the indication for which he or she is being treated and explain concomitant medications. In the second sentence, list the medical history and previous medical and surgical therapies. Some medical reviewers require all drugs and all previous

diseases and injuries to be listed, some reviewers require only drugs, injuries and diseases relevant to the indication and to the event we are reporting. The second paragraph: These sentences discuss the event itself, what happened to the subject before and after and how the investigator handled the event. The first sentence details concisely which study day (in cancer therapy, it will be cycle number and cycle day or study day and cycle number) and what happened in the words of the investigator (do not use preferred terms here). The last sentence explains when and whether the event was resolved and what action the investigator took with the drug. The third paragraph: This paragraph is 1 sentence which lists the medications taken within 2 weeks of the start of the event. Some medical reviewers want all medications and therapies listed, others want only those that are related to the event or related to treating the indication. The medications listed are all listed by generic names, not brand names. If a second serious adverse event has been reported for the subject within 30 days of the last dose of study medication, the fourth and fifth paragraphs will copy the second and third paragraphs. Similarly, if a third or fourth serious adverse event has been reported. The final paragraph: This paragraph is 1 sentence describing concisely the severity of each serious adverse event its relatedness to study medication in the words of the investigator. The event is described by Investigator term, is classified by the NCI scale of severity as determined by the investigator and is either unrelated, of unknown relationship, possibly, probably or definitely related to study medication according to the investigator. The information in this paragraph will come out of the safety reports, it should agree with the information in the database. Queries When Writing the Narratives If data is missing in the clinical database and in the safety report that prevents the medical writer from writing a complete study, the medical writer should query the clinical research associate assigned to the study. If the information is not readily available, the clinical trial site or investigator can be queried. The Statisticians can open the clinical database and change some data and redo the listings if the data is very unclean. Both procedures are very expensive, especially the latter, and are not conducted lightly and not without high level approval. If the data in the clinical database has inaccuracies compared with the safety report, or the safety reports have information gaps and different outcomes than the clinical database, the Safety Officer can arrange to update individual safety reports. Narrative Review Process Getting from a draft narrative to a narrative report that appears in an appendix to the clinical study report usually involves several review processes. The first is my medical writing or whoever is responsible for documentation, the second is by medical reviewers to make sure the narrative makes sense from a medical perspective, the third is by Quality Assurance, to make sure all the pieces fit together and the narrative is accurately represents data from the sources from which it was written. Narrative Template The template will be given directly to individuals who have been trained by Medical Writing in narrative writing. The narrative given below is an example of a real narrative that has been disguised. The font should be Times New Roman. Other style issues, the width of the margins, spaces between lines, wording in each paragraph has been defined in the template and only the template should be used for constructing these narratives.

Reason narrative written: Death: Serious adverse event: Discontinuation due to adverse event: Discontinuation due to laboratory abnormality: Protocol: Subject identifier: Subject demographics: Treatment group: Date of first dose of study drug: Date of last dose of study drug (study day): Preferred term for adverse event:

Gxxxxxx Xxxxx 75-year-old white male Drug p: z mg x y days 29 Mar 2001 05 May 2001 (Day 38) Renal impairment NOS

Narrative: Subject xxxxxx had cancer (disease needs to be specified), which was diagnosed in Jun 1998. The subject previously received treatment with vincristine, dexamethasone, melphalan, and prednisone. The subjects pertinent medical history included cardiac arrhythmia, myocardial infarction, deep vein thrombosis, hypercholesterolemia, acute renal failure, and hypertension. On 30 Apr 2001 (Cycle 1, Day 33; 15 days after completing Cycle 1 therapy), the subject was admitted to the hospital for treatment of acute renal insufficiency. The subject complained of a cough one week before admission, and was treated with a dose of pentamidine for Pneumocystis carinii pneumonia and reported decreased urine output since that time. A baseline 24-hour urine collection on 14 Mar 2001 revealed 75% lambda light chain Bence-Jones protein, a total protein of 2700 mg/24 hours, and a urine M-protein of 2025 mg/24 hours; the investigator considered that the increase in monoclonal proteins was related to a dental abscess. On 27 Mar 2001, his baseline creatinine was 1.9 mg/dL. On admission, the subjects creatinine was 4.9 mg/dL, BUN was 72 mg/dL, and potassium was 5.5 mEq/L. His cloudy yellow urine had 30 mg/dL protein and bacteria (cultured as coagulase-negative Staphylococcus). An abdominal ultrasound showed a slight increase in echogenicity and irregular renal cortices that were consistent with renal disease. A physical examination revealed right lung base crackles and a temperature of 38.1C. On the following day, 01 May 2001, the subjects creatinine was 4.9 mg/dL, BUN was 62 mg/dL, and potassium was 4.7 mEq/L. The subject was discharged on 4 May 2001 (Day 38) with a creatinine of 4.6 mg/dL and a BUN of 65 mg/dL, and the event was considered resolved with sequelae. The subject was given levofloxacin at discharge. A 24-hour urine collection on 24 May 2001 revealed 5.24 g/24 hours Bence-Jones protein, total protein of 5 mg/24 hours, urine M-protein of 4 mg/24 hours, and a creatinine of 4.8 g/24 hours. The subject was discontinued from the study because of progressive multiple myeloma on 29 May 2001. Concomitant medications included albuterol, atenolol, atorvastatin, dalteparin, enalapril, enoxaparin, erythromycin, loratadine, omeprazole, pamidronate, pentamidine, and simvastatin. In the opinion of the investigator, the Grade 3 acute renal insufficiency was unrelated to dexamethasone.

Sample Case narrative:

Following are the Sample of case narrative showing how actually it is written in paragraph format. 1. Example 1 This spontaneous report was received from a physician and concerns a 19 year old male patient from the United States: 100079821DA. The patient's weight was 170 pounds and height was 71 inches. The patient's medical history and concurrent conditions included: diabetes, high blood pressure and neck pain. The patient was treated with amount of zelenium fluoride, acetaminophen (5 mg, tablet, oral, batch 268060LZ, expiry AUG-2012) twice per day, initiated on 01-APR-2011 to 05-APR-2011 for oral care. Concomitant medications included multivitamins for dietary supplement. On 04-APR-2011, the patient experienced gum swelling, blister in throat, bleeding throat and swollen tongue. The patient went to the emergency room on 05-APR-2011. Treatment with zelenium fluoride, acetaminophen was withdrawn. The patient had recovered from the events. Physician had assessed the events as related and company physician had assessed the events as possible. This report was serious. 2. Example 2 this solicited report was received from a physicians assistant via (solicited program name) on 28-AUG-2010. This report concerns a 75-year-old male patient. Additional reporters include the patients wife. The patients weight was 67 inches and weight was 112 pounds. The patients medical history was significant of gout, anxiety, sleep disorder, hypertension, Type II diabetes mellitus, orthopnea and varicose veins diagnosed in 2007). The patients social history included smoking (1 pack a day) and alcohol use (2 drinks/day). The patients family history was significant of hypertension (father) and Type II diabetes mellitus (grandmother). The patient had previously experienced allergy when taking non-company drug X and had previously experienced anaphylactic shock while taking non-company drug Y. The patient initiated treatment with generic name (Trade name, lot#, and expiration date), dose unspecified, and thrice a day in 01-OCT-2010 for the indication of migraine. Concomitant medications included drug A, drug B, drug C and drug D. On 10-OCT-2010 at 10:15 am, 9 days after initiating treatment with company drug, the patient experienced dizziness, dyspnea and hypotension. On the same day at 10:45 am, the patient was rushed to an emergency room where he was admitted for further evaluation. 2 hours after being admitted, the patient experienced a diabetic shock. On 11-OCT-2010, the patient was diagnosed with gastrointestinal bleeding. Treatment medication included x, y, z. Laboratory data was provided as follows: on 10-OCT-2010: blood sugar was XXX, blood pressure was XXX, and hemoglobin was XXX. Treatment with company drug was discontinued on 10OCT-2010. The patient had recovered from the events on 12-OCT-2010 and was discharged home on the same day. The reporter causality was definitely related. Company causality was possible. This report was serious (hospitalization and medically significant) Summary Case Narrative is a part of ICSR narrating comprehensive and complete medical description of the case or AE observed during clinical investigation or post marketing surveillance. It is an important part of pharmacovigilance and patient safety, with case narratives being required for Individual Case Safety Reports, from both clinical and post-marketing studies. The Narrative should serve as a comprehensive, stand-alone medical story. It is usually done by drug safety associate either manually or automatically during case processing process. Mainly three types of narratives are prepared for three different types cases like Clinical, Spontaneous, and literature. It must be compliance with all details to be included and sequence of steps in which narrative is supposed to be written.